April 13, 2011 at 6:44 pm
Recently, the CAFC heard oral arguments for the hotly debated patent lawsuit, AMP et al. v. USPTO et al. (“Myriad“). The roughly one-hour session went more or less as expected. Both sides hammered their respective arguments as much as time would allow, while the Honorable Judges hammered them back with questions about their sometimes flimsy logic. But the Judges were fair and it now looks like Myriad is shaping up to be quite the showdown. Unfortunately, a vital concept enumerated in the District Court’s opinion seems to have been brushed aside this time around. This important concept is the perception of DNA as information; and if taken seriously, it could change everything we currently know about genetics patents.
Isolated DNA != cDNA
Before we address why the dismissal of the District Court’s information theory is a mistake, let’s back-up to the 1980′s. It was during this time that the USPTO began to grant patents for a new* kind of DNA molecule referred to as “isolated DNA.”
* term used loosely
For many years prior to the 1980′s, the USPTO commonly granted patents for novel synthetic manipulations of DNA, called cDNA. The great thing about cDNA is that it is, by definition, synthetic, and therefore not existing in nature. It is the manipulation itself that gives inventive merit to cDNA patents. Conversely, isolated DNA, does exist in nature. Not in “isolated” form, of course, but the structures do exist within living organisms found on Earth. Thus, when we compare isolated DNA with cDNA, there is a readily apparent reduction in the level of inventiveness with the former.
A thing occurring in nature, which is substantially unaltered, is not a “manufacture.” A shrimp with the head and digestive tract removed is an example. Ex parte Grayson, 51 USPQ 413.
It is this canon of patentability, established in 1941, that would seemingly stop an isolated DNA patent application dead in its tracks. To the contrary, however, in 1987 the USPTO began to accept isolated DNA discoveries as patent eligible. Fourteen years and hundreds of isolated DNA patents later, the USPTO then went as far as to explicitly create an official subcategory for isolated DNA.
An inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it. Utility Examination Guidelines, 66 Fed. Reg. 1092.
And so this line of thinking became official USPTO policy.
The problem with DNA
Supporters of isolated DNA patents will argue tooth and nail that isolated DNA is not found in nature, because it is not found in nature in isolated form. And this is basically the entire argument. The whole thing hinges on the determination of whether or not, within the scope of Congressional intent and § 101, isolated DNA is “occurring in nature.”
So then why is this a hard decision for the Court? It seems obvious to the casual observer that isolated DNA is in fact naturally occurring. We can all see through opportunistic corporate applicants with steady hands and really, really small scissors trying to splice the human code into nice little patentable packets of money. So what is the problem? Why can’t the courts just label isolated DNA discoveries as unpatentable subject matter and get on with it?
Answer: because the arguments presented by opponents of isolated DNA are not convincing.
One thing that became painfully apparent while listening to oral arguments is that both sides seem destined to do battle with the “natural resources” analogies.
Example: if you break apart naturally occurring salt compounds to reveal pure Lithium, you cannot then patent Lithium, even though Lithium does not naturally exist in isolated form.
This is the analogy most relied upon by the Plaintiffs in Myriad. It is flawed, however, because it relies on the assumption that any extracted substance found in nature must be the fundamental equivalent of an Element on the Periodic Table. Of course, not everything found in nature is as fundamental as the Elements, and therein lies a conundrum: how far removed from Elements should we begin to allow patentability for newly discovered substances? Thus far, it seems that somewhere between DNA’s main components [Nitrogen+Hydrogen+Oxygen] and DNA itself, the threshold between “naturally occurring” and “patentable” gets breached. Therefore, any argument that attempts to analogize the DNA with Elements is destined to fight an uphill battle. Even worse, such analogies fail to challenge the current notion that DNA is just another chemical substance.
DNA is Information
In order to make a truly convincing argument that isolated DNA is naturally occurring, we need to stop thinking of DNA as some magical substance that can be bottled and sold at the Traveling Medicine Show, and start recognizing it for what it really is: information. Unlike fossil fuels or plastics, DNA does not possess any inherent value as a raw chemical substance. We can’t use DNA to weatherproof our clothes or keep our knives sharp. Frankly, the only reason that DNA has any value at all, is because it is information.
DNA is most certainly information, but referring to it as just “information” is something of a slight. DNA is, quite literally, carefully programmed data. That data gets fed into biological computers that, by some miracle of evolution, know exactly what to do with it. The fact that this data happens to be coded with entirely organic compounds does not somehow change its divine purpose or reduce its existence to “just another string of covalent bonds” (as is often heard in the courts).
When the Myriad case first went to trial, the District Court took the view that, even if isolated DNA was believed to be unnatural, DNA itself is the “biological carrier of naturally occurring information.” This alternative thinking – albeit completely logical – was a bombshell to the Defendants. Until then, DNA had been treated no different than any other organic compound found in nature. The implications of this information theory were massive.
To illustrate this point, let’s steal a concept from theoretical physics. It is postulated by Steven Hawking and other black hole experts that every bit of information about the contents of a black hole is stored on its two-dimensional surface area that makes up the event horizon. Similarly, according to the Holographic Principle, all space and time contained within a body with “N” dimensions can be described by the scattered information that exists on the “N-1″ dimensional surface of the body.
So what does this have to do with DNA? Well, let’s assume for a moment that we could travel to the surface of our Universe and somehow trap the information it contained. If we were then able to decode and organize this trapped information, theoretically we could uncover the secrets of everything contained in our Universe. If we were able to dive deep enough into the data, we could find the solutions to all that ails us, in perfect little packets of data. Would those packets of cosmic information be considered patentable subject matter? Not likely.
Now shrink it down. Instead of a cosmic bubble of universal information flying about our heavens, reduce it to microscopic levels and cull the data to only organic instructions for whatever living body contains it. Now trap it, decode it, and slice it up into useful little packets. Congratulations, you’ve just isolated some DNA. Now go get your pat- wait a second, how is this any different than the cosmic example?
Admittedly, the information-carrying DNA in humans is not located on our N-1 surface plane; however, the way we treat information should remain the same. All packeted information that is extracted and isolated from a naturally occurring body of information must also be naturally occurring. To hold otherwise would be a logical fallacy of the highest order.
Unfortunately, if you listen to the oral arguments, you will find disappointment at the 50 minute mark. The information theory has been explicitly discarded. The parties make it clear that they will each attempt to shoehorn DNA into the one-size-fits-all precedent of chemical substances, and let the battle hinge on bad analogies and public policy. At this stage, it is unclear which side will prevail at the Appellate level. But in light of precedent, USPTO authority, and conviction of the arguments, it would not be a surprise to see the District Court’s decision get completely reversed.
So here’s hoping for certiorari. Perhaps the SCOTUS will have the wherewithal to see DNA for what it truly is, and adjust our patent system accordingly.